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Willebrand International Non-interventional Global Surveillance

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ClinicalTrials.gov Identifier: NCT01949220
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies

Brief Summary:
Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.

Condition or disease
Von Willebrand Disease

Detailed Description:
Non-interventional, prospective, non comparative, international, multicentre study.

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.
Actual Study Start Date : March 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Von Willebrand factor deficient patient
Inherited von Willebrand disease



Primary Outcome Measures :
  1. Documentation of product consumption data [ Time Frame: at each follow-up visit, up to 24 months ]
    Product consumption (VWF International Units) by analysis of posology, frequency in relation to the severity of bleeding, type of surgery and other clinical situations.


Secondary Outcome Measures :
  1. Collection and analysis of adverse events and VWF immunological safety [ Time Frame: at each follow-up visit, up to 24 months ]
    Adverse event (type, seriousness, severity, frequency, outcome), anti VWF-antibody and anti FVIII-antibody.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient, whatever their age, with inherited von Willebrand disease
Criteria

Inclusion Criteria:

  • Patients with inherited von Willebrand disease
  • Patients treated with WILLFACT or WILFACTIN
  • Patient or parent/legal representative who has provided written signed and dated informed consent before any data collection.

Exclusion Criteria:

  • Patients who usually do not keep injection log up to date, when treated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949220


Locations
Belgium
Hopital des enfants Reine Fabiola
Antwerpen, Belgium
UZA hopital universitaire
Edegem, Belgium, 2650
Czechia
University Hospital
Brno, Czechia, 625 00
Finland
University Central Hospital
Helsinki, Finland
Germany
Charité Universitätsmedizin
Berlin, Germany
GZRR Gerinnungszentrum Rhein/ Ruhr
Duisburg, Germany
Universitatsklinikum
Essen, Germany
Goethe Universitat
Frankfurt, Germany, 60590
Medizinische Hochschule Hannover
Hannover, Germany
Werlhof-Institut für Hämostaseologie GmbH
Hannover, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Universitatsklinikum
Mainz, Germany
Klinikum der Universität
München, Germany
Greece
Hemophilia center "LAIKO" general hospital
Athens, Greece
Italy
Centro di Riferimento Regionale per Emofilia e Trombosi
Catania, Italy
AOUC- Azienda Ospedaliero-Universitaria Carregi
Firenze, Italy
University of Milan
Milan, Italy, 20122
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
Study Director: Wolfgang MIESBACH, Dr Medizinische Klinik III, Goethe Universitat, D-60590 Frankfurt/Main (Germany)
Study Director: Flora PEYVANDI, Prof. Faculty of Medicine, University of Milan, 20122 Milan (Italy)

Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT01949220     History of Changes
Other Study ID Numbers: WINGS
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:
Inherited
Von Willebrand disease
Von Willebrand factor
Deficiency
safety

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn